Heyuan Bio's CD19 CAR-T Therapy Yuanruida® (Najiorlunsa Injection) Approved for Market Launch in China

Nov 08, 2023 12:02 CST Updated 12:03

Juventas

Innovative Cell Therapy Drug Developer

On November 8, 2023, the official website of China's National Medical Products Administration (NMPA) showed that the "Natruevocel Injection" submitted by Juventas (Tianjin) Biotechnology Co., Ltd. (Juventas) has been conditionally approved for marketing through the priority review and approval process (brand name: Yuanruida), indicated for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

Notably, Naciorl Injection is the third CD19 CAR-T cell therapy approved by NMPA and also the first CAR-T therapy approved in China for treating B-cell acute lymphoblastic leukemia.

In addition, Juventas' Nakiolumab InjectionStillChina's First CD19 CAR-T with Independent Intellectual Property Rights LaunchedProduct, which has a globally unique CD19 scFv (HI19a) structure.

Further Reading:First China-produced CD19 CAR-T Therapy Submits for Market Approval

In 2022American Society of Hematology (ASH)Up,JuventasReported on the injection of Naciorlen (Herkylone Injection) Key clinical trial data for treating adult r/r B-ALL.

Clinical data show that the overall response rate (ORR) reached 82.1%, and the complete response (CR) rate reached 66.7%. The MRD-negative rates at 3 months and within 3 months for patients achieving CR or CRi were 92% and 100%, respectively.

At a median follow-up of 9.3 months, the median duration of response (DOR) has not yet been reached. As of the data cutoff date, the longest duration of response without subsequent hematopoietic stem cell transplantation has exceeded 18 months and is still ongoing. Additionally, the long-term persistence of Herclues CAR-T cells can be detected in vivo.

At a median follow-up of 8.0 months, neither the median recurrence-free survival (RFS) nor overall survival (OS) had been reached.

In terms of safety, no adverse events occurred as a result of the unintended targeting of CD19 CAR-T therapy. The incidence of Grade 3 or higher cytokine release syndrome (CRS) was 10.3%, and the incidence of Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS) was 7.7%. All cases of Grade 3 or higher CRS and ICANS were resolved, with no CRS/ICANS-related deaths reported.

Summary

Juventas' Najiolumab Injection is the fourth CAR-T cell therapy product to be launched in China. Based on previous filings, two more BCMA CAR-T therapies are likely to be approved for marketing subsequently.

As an increasing number of CAR-T cell products are approved for marketing, providing new treatment options for cancer patients, cell and gene therapy is gradually becoming one of the major pillars of cancer treatment in China.

References:

1. Juventas Biotechnology: "Juventas Biotechnology's New Drug Application for Hericlen Injection Granted Priority Review by the National Medical Products Administration"

2.https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20231108092415187.html

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